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Oculis Announces First Patient First Visit in Phase 2b RELIEF Trial of Topical Anti-TNFα Licaminlimab (OCS-02) in Dry Eye Disease
Licaminlimab is a novel anti-TNFα biologic eye drop with an established dual mechanism of action, anti-inflammatory and anti-apoptotic, and a potential
About this update from Oculis Holding Ag
[{"type":"text","content":"Licaminlimab is a novel anti-TNFα biologic eye drop with an established dual mechanism of action, anti-inflammatory and anti-apoptotic, and a potential transformative impact on the treatment of inflammatory eye diseasesRELIEF Phase 2b trial will evaluate the efficacy and safety of licaminlimab in moderate-to-severe Dry Eye Disease, and further explore the potential of a genetic biomarkerTrial was initiated as planned with topline results expected in mid-2024 ZUG, Switzerland and BOSTON, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces First Patient First Visit (FPFV) in its Phase 2b RELIEF trial evaluating the potential of licaminlimab (also known as OCS-02), Oculis’ innovative anti-TNFα biologic eye drop, for the treatment of Dry Eye Disease (DED). The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of licaminlimab for the treatment of signs and symptoms in moderate- to-severe DED. Furthermore, the trial will evaluate if patients with a specific genetic biomarker identified in a prior trial respond better to licaminlimab. The trial was designed after several trials with licaminlimab in DED and Uveitis demonstrated positive findings. 120 patients are planned to be randomized to either licaminlimab or vehicle for a 6-week treatment and a 2-week follow up period. Topline results are anticipated in mid-2024. Riad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “We are very pleased to have achieved First Patient First Visit (FPFV) in the RELIEF trial as planned. The initiation of this trial represents a key milestone as we advance the development of OCS-02, a promising, differentiated candidate in Dry Eye. This achievement builds on our earlier successes this year with positive Phase 3 results from our other lead asset, OCS-01, in diabetic macular edema and post ocular surgery. DED remains an area of unmet medical need with only 13% of patients achieving lasting relief after 12 months of treatment in a large and growing market affecting approximately 40 million patients in the U.S. We are confident that licaminlimab, given its proven mechanism of action and its prior clinical trials results, will have transformative...